Description

This pilot clinical trial studies the side effects of zirconium Zr 89 trastuzumab and to see how well it works with positron emission tomography (PET) in detecting tumors in patients with human epidermal growth factor 2 (HER2) positive esophagogastric cancer. Radioactive substances, such as zirconium Zr 89, linked to monoclonal antibodies, such as trastuzumab, can bind to tumor cells and give off radiation which may help kill tumor cells and may help determine HER2 positive tumor cells through PET imaging.

Eligibility Criteria

Inclusion Criteria

Registered patient at Memorial Sloan-Kettering Cancer Center (MSKCC)

Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer; HER2 positive status by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) as currently being implemented for patients with esophagogastric cancer; HER2 overexpression and/or amplification as determined by IHC (3+) or FISH (>= 2.0)

Measurable or evaluable disease, lesions that have not been previously radiated, with clinically indicated imaging evaluation performed within 4 weeks prior to study entry (computed tomography [CT], magnetic resonance imaging [MRI], fluorodeoxyglucose [FDG]-PET or bone scan); patients requiring concurrent radiation treatment are not eligible unless additional lesions that are not being irradiated and are assessable for targeting are present

Karnofsky performance score >= 60

Ability to understand and willingness to sign informed consent

Negative pregnancy test, to be performed on female patients of childbearing potential within 1 week before administration of radioactive material

Life expectancy of at least three (3) months

Willingness to use birth control while on study

The patients will be asked to consent to provide access to data obtained from molecular analysis that has been done on archived tumor tissue that will be correlated with 89Zr-DFO-trastuzumab imaging results

Concurrent therapy will be allowed

Exclusion Criteria

Inability to lie still for the duration of the scanning procedure

Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or desferrioxamine [DFO] or trastuzumab)

Patients who have received trastuzumab must have at least a washout period for trastuzumab of 14 days, this will not apply to 89Zr-DFO-trastuzumab repeat, post treatment assessment where patients may be receiving trastuzumab

II. Patients who have archived tissue or will be having a clinically indicated biopsy will be asked to consent to have this tissue made available for molecular analysis of their tumor to correlate with imaging results.

III. Evaluate imaging results with response to treatment.

OUTLINE:

Patients receive zirconium Zr 89 trastuzumab intravenously (IV) over 5-10 minutes. The first 10 patients undergo PET imaging 1-4 hours, 24 hours, 48-96 hours, and 120-192 hours post injection and subsequent patients undergo PET imaging at a single optimal time point based on the first 10 patients. Patients receiving standard of care therapies directed at HER2 may receive an optional repeat treatment and imaging 2-6 weeks after the start of the standard of care treatment.

After completion of study treatment, patients will be followed up after 2 weeks.